Do No Harm: Putting Safer Pain Management Guidelines into

Practice – Module 5

1.1 Introduction

Welcome to the Oklahoma Primary Healthcare Improvement Cooperative’s online course - Do No

Harm: Putting Safer Pain Management Guidelines into Practice.

This Online Enduring Material educational program is designed for healthcare professionals. The

contents of this program are based on the National Academy’s Institute of Medicine’s white paper

Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks

of Prescription Opioid Use and the 2016 CDC, 2017 VA-DOD, 2017 Oklahoma State Department

of Health Guidelines for Pain and Opioid management, and Oklahoma law.

The program was developed through a grant from the Oklahoma Department of Mental Health

and Substance Abuse Services by the Oklahoma Primary Healthcare Improvement Cooperative of

The University of Oklahoma Health Sciences Center and the OU-TU School of Community

Medicine. It was released in August, 2019.

1.2 Overview

Hi, I’m Steve Crawford, and I will be your guide through Patient Engagement, the fifth module in

the Do No Harm: Implementing Safer Pain Management in Practice.

This module will help you apply the principles of patient education and documentation of

informed consent to use opioid medications as a component of a multi-modal chronic pain

treatment plan. The module is designed to stand-alone among the other five modules of this

course. Therefore, some of the slides and questions may be similar to those appearing in other

modules.

The average time to complete this module is 30 minutes and ½ hour CME credit is available from

OU Continuing Professional Development Office by registering, passing a small quiz, and

evaluating the course. Directions will be provided at the conclusion of this module.

1.3 Planning and review Committees

The panel of experts who reviewed this course represent primary care clinicians, pharmacists,

educators, and specialists in pain, addiction, and palliative care, and a national expert in the

epidemiology of the opioid crisis.

1.4 Relevant Disclosure and Resolution

None of the members of the CME Planning committee have a relevant financial relationship or

affiliation with commercial interests to disclose.

1.5 Relevant Disclosure and Resolution for Expert Review Panel

None of the expert reviewers have a relevant financial relationship or affiliation with commercial

interests to disclose.

1.6

Conflict Resolution Statement:

The University of Oklahoma, College of Medicine Office of Continuing Professional Development

has reviewed this activity’s speaker and planner disclosures and resolved all identified conflicts of

interest, if applicable.

Policy on Faculty and Presenters Disclosure:

It is the policy of the University of Oklahoma, College of Medicine that the faculty and presenters

disclose real or apparent conflicts of interest relating to the topics of this educational activity, and

also disclose discussions of unlabeled and/or unapproved uses of drugs or devise during their

presentation(s).

Disclaimer Statement:

Statements, opinions and results of studies contained in the program are those of the presenters

and authors and do not reflect the policy or position of the Board of Regents of the University of

Oklahoma (“OU”) or the Oklahoma Department of Mental Health and Substance Abuse Services

(“ODMHSAS”) nor does OU/ODMHSAS provide any warranty as to their accuracy or reliability.

Every reasonable effort has been made to faithfully reproduce the presentations and material as

submitted. However, no responsibility is assumed by OU/ODMHSAS for any claims, injury and/or

damage to persons or property from any cause, including negligence or otherwise, or from any

use or operation of any methods, products, instruments or ideas contained in the material herein.

Nondiscrimination Statement:

The University of Oklahoma, in compliance with all applicable federal and state laws and

regulations does not discriminate on the basis of race, color, national origin, sex, sexual

orientation, genetic information, gender identity, gender expression, age, religion, disability,

political beliefs, or status as a veteran in any of its policies, practices, or procedures. This includes,

but is not limited to: admissions, employment, financial aid, and educational services. Inquiries

regarding non-discrimination policies may be directed to: Bobby J. Mason, University Equal

Opportunity Office and Title IX Coordinator, (405)325-3546, bjm@ou.edu, or

visit www.ou.edu/eoo.

Accommodation Statement:

Accommodations are available by contacting Jan Quayle at 405-271-2350, ext. 8 or e-mail to: jan-

quayle@ouhsc.edu.

1.7 Professional Practice Gap Being Addressed

The knowledge gap being addressed in this module is that Oklahoma healthcare providers may

lack knowledge and confidence in their competence to engage patients in shared decision making,

giving informed consent, and participating in their chronic pain care.

1.8 Objectives

After completing this module, you should be able to develop a patient-centered pain

management plan that reinforces patient understanding and shared decision of the risks, benefits,

and responsibilities of treatment. You will also learn how to negotiate a signed pain treatment

agreement, provide patient education in the safe use, storage, and disposal of controlled

substance. You will be able to educate patients, caregivers, and family members how to recognize

signs of intoxication, overdose, and how to use naloxone for rescue and resuscitation.

1.9 Patient and Practice Education

When opioid medications are prescribed for the first time for chronic pain, education includes the

message that controlled substances have limited benefits for chronic pain and substantial risks

for addiction including accidental intoxication injury and death.

Clinicians may have in their practice or be referred “legacy patients” who have been taking opioids

in higher doses than current guidelines. Some may have satisfactory function and pain control at

higher doses than guidelines recommend for safer opioid prescribing. Patient education for these

patients involves establishing a trusting relationship in which the clinician agrees to help the

patient live and function well, including continual assessment of risk and benefit of opioid therapy,

careful monitoring of opioid use for adverse effects and tapering to safer doses.

Patient education includes helping patients understand their responsibility for safer use of opioids

that includes a policy that lost or stolen medication will not be routinely replaced or refilled early.

Concurrent use of sedating medications (such as benzodiazepines and muscle relaxants) increases

the risk of intoxication, injury, and death and will therefore be judiciously managed or

discontinued. Patients agree to contact their clinician if they have adverse effects. Finally,

naloxone will be made available and family and friends whom staff and pharmacies will teach how

to use it.

1.10 Pain Management Plan

Care for patients suffering from chronic pain begins with the clinician engaging the patient and, if

appropriate, caregiver, in a shared decision making conversation. The clinician names the

diagnosis and describes the prognosis for patient’s life, functionality, and well-being. Clinicians

help patients understand that the goal of chronic pain management is to improve function, and

reduce pain’s interference with daily function. Unfortunately, some patients have suffered with

chronic painful and debilitating conditions for years and improvement in function will be modest

at best. Multiple approaches will be used to do no harm, improve the overall health of the patient,

incorporate mind-body therapy, and the judicious use of medications.

1.11 Informed Consent for Opioid Treatment

Oklahoma law requires clinicians to document a written Patient-Provider Agreement, which is a

pain management agreement with informed consent to use opioid medications. The agreement

describes the goals of treatment and the risks involved in taking opioid medications. It provides

an opportunity to clarify patient and physician expectations for treatment and their mutual

responsibilities. It enhances adherence, promotes a therapeutic alliance, and obtains informed

consent, thereby serving the ethical obligations inherent in patient care. The agreement or

consent provides documentation of the grounds for continuation or discontinuation of therapy

thus providing a clear pathway for tapering and discontinuing chronic opioid therapy when risk

exceeds benefit because of personal risk to the patient related to misuse, addiction, overdose, or

risk to the public from diversion, or both. Patients must agree that ongoing assessment and

treatment of mental health conditions are central to the plan, and that opioids may be tapered

and discontinued if they refuse continuing mental health evaluation and therapies.

1.12 Consent to Knowing Risks of Opioid Use

The patient-provider agreement and informed consent to use opioids documents the patient’s

understanding of the limited benefits of opioid medications and the substantial risks of use, the

components of which are listed on this slide. The patient treatment agreement includes patient

responsibilities to read all instructions, take medications as prescribed, check labels to confirm

the contents of the bottle and do not transfer medications to other containers. Never use expired

medications, and properly dispose of unused or expired medication. Store controlled substances

in a locked container. Call 211 for information on addiction diagnosis and treatment and post the

poison control number (1-800-222-1222) on cell phones and land-line phones.

1.13 Safe Disposal of Controlled Substances

The Oklahoma campaign, “OK I’m Ready” has a listing of community prescription drug take-back

locations. Pharmacies also may have medication disposal or deactivation pouches. When a take-

back service is not available, controlled substances may be disposed in household trash by using

a sealed plastic bag, and mixing the medicine with unpalatable or disgusting substances. Make

certain to scratch out information on disposed prescription containers. Because of the danger of

having some medications in the trash the FDA has established a “Flush List” of medications that

can be flushed only when take back options are not readily available.

1.14 Changing Direction for Legacy Patients

Most patients will be harmed by experiencing withdrawal syndrome when a chronic, stable opioid

dose is interrupted or rapidly decreased. Withdrawal may be severe and may include cramps,

vomiting, sweating, fever, anxiety, self-treatment, and drug-seeking if opioid use disorder has

developed.

The suggested approach to changing direction for legacy patients is to first do no harm! DO NOT

abruptly stop opioid medications or dismiss guideline discordant patients from your practice.

Provide patient education about the new expectations and work closely with the patient to

implement safer plans that include reduced dosing. Prescribe naloxone to prevent overdose

deaths. Slowly taper opioids and discontinue risky combinations when possible. If progress is slow

or plateaus, do not abandon your patient! Be compassionate and persistent. Carefully manage

withdrawal symptoms if they occur, and remain vigilant for substance or opioid use disorders that

may become apparent during the weaning process. Refer patients for addiction treatment

services or prescribe dependence medications such as buprenorphine when indicated.

The video link on this slide offers additional case training in collaborative opioid tapering.

1.15 Monitor for Opioid Misuse

Inform patients that they will have face-to-face visits every 1 to 3 months when taking opioids, in

order to monitor for the development of harms from opioids, particularly risk for overdose and

the development of opioid use disorder. Screening for harm or misuse of opioids includes routine

checking the Oklahoma Prescription Drug Monitoring Database for other prescribers and other

controlled medication prescriptions, performing random in-office or laboratory urine drug testing,

possibly performing random pill counts, and checking for aberrant behaviors to screen for

developing opioid use disorder or other misuse. Many patients develop tolerance and may

request dose increases. Tolerance or withdrawal symptoms can exist without a diagnosed opioid

use disorder. However, along with other symptoms such craving, obsessive worry about having

enough opioids, and appearance, behavior, and social changes, opioid misuse or disorder may be

present and requires a thorough assessment. Patients who are misusing opioids, or are

developing opioid use disorder may be ashamed or reluctant to discuss their condition openly

with their clinician. They may fear being cut off from their opioid supply. A non-judgmental,

therapeutic approach discussing opioid use disorder to be a serious, but treatable medical

condition, may support patient safety and honesty.

1.16 Signs of Possible Opioid Misuse

Patient and family education about the clues to developing opioid problems is important. You

should inform patients and family that it may not be easy to tell if someone close is developing

opioid problems, especially in the early stages. Anyone who uses opioids can become addicted,

even when they are prescribed by a doctor. The family or patient may notice changes in moods

or behavior or the family member’s intuition may be suggesting a problem. Advise the family that

speaking up could save the life of someone dear to you.

Some of the signs of a problem may include regularly taking an opioid in a way not intended by

the doctor who prescribed it, including taking more than the prescribed dose or taking the drug

for intoxication. Taking opioids "just in case," even when not in pain is an important clue. The

person using opioids may be spending excessive time obtaining, using or recovering from them.

They may begin craving opioids. They may continue opioid use even when it is associated with

inability to fulfill responsibilities, or despite having persistent social or interpersonal problems.

They may reduce involvement in social, occupational or recreational activities. Signs of opioid

intoxication and increased risk for overdose include pinpoint pupils, drowsiness, and slurred

speech.

Some addiction experts now recommend that doctors interview family members as part of

routine follow-up care for a person taking opioid medications. Family should be advised not to

wait to be asked before voicing concerns. A person addicted to opioids - or any substance - is

much more likely to recover if his or her family refuses to ignore or tolerate the problem. If family

thinks a loved one may be addicted to opioids, it is important to talk with his or her doctor right

away. Together they can determine the best next steps. Patients or family may call 211 or visit

OKImReady.org for more resources.

1.17 Supporting a Loved One in Recovery

The clinician’s practice can educate loved ones of patients with opioid or other substance use

disorder in how they might be helpful in supporting recovery. The first concept is that opioid use

disorder is not a moral failing, but a serious chronic brain disease. We recommend calling 211 or

visiting the OKIMREADY.org web site for treatment resources and free opioid overdose

prevention medication, naloxone. The web sites on this page provide other helpful information

for families.

The most important support for persons in recovery are improving overall HEALTH by helping the

loved one make informed healthy choices that support physical and emotional well-being.

Assuring a safe, stable HOME, possibly even a sober living house is important. Supporting a life

PURPOSE is helping the loved one conduct meaningful daily activities and having the

independence, income, and resources to participate in society. These are often available through

the human resources referral to treatment by employers and by community resources for

recovery. A recovery COMMUNITY supports the loved one to develop relationships and social

networks that foster friendship, love, and hope. Peer support organizations for the recovering

person and family members may be helpful in providing additional support.

1.18 DSM-5 Criteria for Opioid Use Disorder

You may wish to show patients and their family the criteria for diagnosis of Opioid Use Disorder.

Explain that OUD is a problematic pattern of opioid use leading to clinically significant impairment.

In order to confirm a diagnosis of OUD, at least two of the DSM-5 criteria should be observed

within a 12-month period: Loss of control exhibited by (1) taking opioids in larger amounts or

over a longer period than was intended; (2) having a persistent desire or unsuccessful efforts to

cut down or control opioid use; or (3) spending a great deal of time in activities necessary to obtain,

use, or recover from opioid effects. (4) Craving is having a strong desire or urge to use opioids.

Adverse consequences include: (5) recurrent opioid use resulting in a failure to fulfill major role

obligations at work, school, or home; (6) continued opioid use despite having persistent or

recurrent social or interpersonal problems caused or exacerbated by the effects of opioids; (7)

giving up or reducing important social, occupational, or recreational activities because of opioid

use; (8) recurrent opioid use in physically hazardous situations; or (9) continued opioid use despite

knowledge that persistent or recurrent physical or psychological problem are likely to have been

caused or exacerbated by the substance.

The last two diagnostic criteria, tolerance and withdrawal, without other symptoms, are not

considered to be met for individuals taking opioids under appropriate medical supervision.

Tolerance, is a need for markedly increased amounts of opioids to achieve intoxication or desired

effect, or having a markedly diminished effect with continued use of the same amount of an opioid.

There are two criteria for Withdrawal Syndrome: A) after stopping or reducing opioid dose

following heavy or prolonged use, or after administering an opioid antagonist; and B) within

minutes or days, three or more of the following develop: dysphoric mood, nausea or vomiting,

muscle aches, lacrimation or rhinorrhea, pupillary dilation, piloerection, sweating, diarrhea,

yawning, fever, or insomnia.

1.19 Managing Opioid Use Disorder

When OUD is suspected, the diagnosis should be confirmed with a thorough history and physical

examination, urine drug screen and review of the prescription drug monitoring program. Patients

may show no physical signs of opioid addiction. The diagnosis relies on respectful and supportive

history of the patient’s experience with opioids. Clinicians may use the DSM-5 criteria to make a

diagnosis or arrange for an assessment by a specialist in addiction. Referrals for Oklahoma are

found on the OKI’mReady.org website.

The DSM-5 criteria for diagnosis of t OUD as occurring on a continuum of severity. A scale for

assigning severity was developed in DMS-5 and is based upon the number of criteria that have

been met (2-3 for mild, 4-5 for moderate, and more than 6 for severe). This severity distinction

has treatment implications.

When OUD is diagnosed, it is important to treat the patient like anyone with a serious, potentially

fatal chronic illness. Patients may experience shame and abandonment when addiction is

identified. Clinicians should state that they will not dismiss the patient from primary care and will

continue to help manage their underlying or co-occurring diseases or conditions. Approaching the

patient with compassion helps determine the effect opioid use has had on physical and

psychological functioning. The therapeutic relationship will be enhanced by empathizing with the

patient’s experience and outcomes of past treatment episodes. Clinicians should express concern

about the patient's potential for overdose. Risk factors for overdose include a past history of

overdose, a past history of substance use disorder, opioid dosages >50 MME/day, and concurrent

benzodiazepine use. When one or more of these risk factors are present, clinicians should educate

the patient and his or her family about the symptoms of opioid overdose and how to administer

naloxone. For more information about naloxone, visit OKImReady.org. The clinician and practice

staff should re-inforce the patient that OUD is a treatable, serious medical condition and

arrangements for evidence-based treatment will be made.

1.20 Overdose - Save a Life

Patients, family members, and caretakers should be taught opioid overdose resuscitation. When

a person is found down with evidence of prior use of opioids such as needle and syringe or bottle

of pills, overdose is highly likely. Overdose may be more difficult to recognize when an older

person with multiple medical problems and prescribed opioid medications is found to be confused

or unarousable. Resuscitation steps are “shake and shout” calling the patient’s name to wake up.

If no response, lay the person on their side and call for help. Do not leave them alone. Call or

have someone else call 911. Administer intranasal naloxone. If the person is not breathing, do

rescue breathing and chest compressions. Stay with the person until help arrives.

1.21 NARCAN Training Video

1.22 OK I’m Ready

The Oklahoma campaign, “OK I’m Ready” launched by the Oklahoma Department of Mental

Health and Substance Abuse Services hosts a website with public and patient information about

the opioid crisis in Oklahoma. It contains information about preventing opioid problems, treating

opioid use disorder, and responding to opioid overdose. Available resources across the state are

provided.

1.23 Conclusion

In summary, a patient-centered management plan includes patient education on the risks,

benefits, and responsibilities of using opioid medications to treat chronic pain and shared decision

making to use opioid medications with its possible benefits and substantial risks. It includes

negotiating and documenting a mutually agreed upon plan in a signed pain treatment agreement

with informed consent, educating the patient, family and caregivers on the safe use, storage, and

disposal of controlled substances and the recognition of addiction, intoxication, overdose, and

the rescue use of naloxone.

1.24 Instructions

Please answer the following self-assessment question by selecting the single best answer. You

will receive immediate feedback and if you selected an incorrect response you may answer the

question again.

1.25

Question 1

1.26

Question 2

1.27

Question 3

1.28

Question 4

1.29

Question 5

1.30 Resources

The references on this slide and the next slide provide additional resources for making changes in

practice systems needed to implement practice guidelines.

1.31 Resources

The references on this slide are provided for your additional information. Thank you for

participating in this online program.

1.32 Closing Instructions

You may print a certificate of completion in order to meet the requirements for annual training

by clicking on the reports tab.

In addition, the University of Oklahoma Office of Professional Development is providing CE credits.

MDs are eligible for AMA PRA Category 1 Credit, Physician Assistants for AAPA Category 1 Credit,

and Nurse Practitioners for AANC contact hours and Oklahoma pharmacology hours.

Until March 1, 2020, the University of Oklahoma will waive the $25 fee.

Click on the web link which will take you to the Office of Professional Development web site where

you may register, take a test of knowledge, evaluate your learning experience, and print your CE

certificate.